Arthrogen, a clinical stage gene therapy company together with the Centre for Human Drug Research (CHDR), announced that the first three arthritis patients have been enrolled in a phase Ib gene therapy trial for treatment of arthritis with ART-I02.

ART-I02 is an adeno-associated virus (AAV5) vector encoding the human IFN-β gene under control of an inflammation-responsive promoter. ART-I02 is designed to produce the anti-inflammatory protein IFNβ in the synovial cells in the joint. The aim is to achieve a sustained clinical remission with a single treatment. This current clinical phase Ib trial, evaluates the safety, tolerability, pharmacokinetics, immunogenicity and anti-inflammatory activity of ART-I02 treatment in patients with rheumatoid arthritis (RA) or osteoarthritis (OA). In total 12 patients with RA or OA in their hand joints will be included. Parallel to this study, a similar phase Ib trial has started in Canada treating 15 patients with RA in their wrist.

“Patients with rheumatoid arthritis and osteoarthritis face chronic pain and immobility, even despite the availability of new, mostly systemic treatments.”, explains principal investigator Prof. dr. Koos Burggraaf of CHDR and he continuous: “In this trial we evaluate the safety of ART-I02 and we assess effect measures, hoping that this first step may prove to be an important milestone marking a new era in the treatment of arthritis, a chronic debilitating disease.”.

Robert Jan Lamers, Chief Executive Officer of Arthrogen comments ‘We would like to thank our investors, collaborators and participating patients in helping us achieve this pivotal milestone. Based on anticipated enrollment and follow-up timelines, the first set of data is expected to be available in the fourth quarter of 2018’.